Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment

(IMPACT Trial)

Recruiting at 2 trial locations

Overseen By TBN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Methadone, Buprenorphine

Disqualifiers: Bipolar, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators plan to develop and pilot test an integrated, web-based cognitive behavioral approach and then conduct a randomized clinical trial evaluating its efficacy relative to standard care in a large and diverse sample of individuals with chronic pain treated with buprenorphine or methadone. The new program will retain key components of Dr. Carroll's computer-based training for cognitive-behavioral therapy (CBT4CBT), including its emphasis on teaching cognitive and behavioral coping skills in an engaging way and focus on the 5 A's of MAT (Adherence, Attendance, Abstinence, Alternate Activities and Accessing support); it will add components from Dr. Heapy's COPES (Cooperative Pain Education and Self-Management) intervention (self-management of chronic pain, with daily surveys via text that monitor pain intensity and interference, physical activity, and skills practice) and modify existing CBT4CBT modules to address the complex interplay between pain and drug use in this population, emphasizing the development of generalizable skills. A randomized clinical trial evaluating CBT4CBT-COPES will be conducted in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or buprenorphine) who have chronic pain, in a 3-month randomized clinical trial with a 6-month follow-up, comparing it to standard treatment alone. The primary retention outcome will be adherence with agonist treatment; the primary pain outcome will be the PROMIS 6-item Pain Interference Short Form.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, participants must be enrolled in methadone or buprenorphine treatment, so you should continue those medications.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require participants to be on methadone or buprenorphine treatment.

What data supports the idea that Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment is an effective treatment?

The available research shows that Computer-Based Cognitive Behavioral Therapy (CBT) for chronic pain is effective. Studies indicate that CBT helps people manage chronic pain and improve their outcomes. For example, the COPES trial found that technology-assisted CBT is as effective as in-person therapy for chronic back pain. Additionally, web-based CBT has been shown to increase access to pain management and is comparable in effectiveness to face-to-face therapy. These findings suggest that computer-based CBT is a promising alternative for those who cannot access traditional therapy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CBT4CBT COPES for chronic pain in opioid treatment?

Cognitive behavioral therapy (CBT) has been shown to help manage chronic pain and improve outcomes, and technology-assisted delivery of CBT can maintain its effectiveness while improving access. Studies have found that web-based CBT can be as effective as in-person therapy for chronic pain management. ^{1 2 3 4 5}

What safety data exists for computer-based CBT for chronic pain?

The research indicates that cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Multiple studies have shown that CBT-CP is an evidence-based treatment that improves pain management and outcomes. Technology-assisted delivery of CBT, such as through interactive voice response or web-based platforms, can maintain efficacy while improving access, although specific safety data for these formats is not detailed in the provided abstracts. ^{1 2 3 4 6}

Is computer-based cognitive behavioral therapy for chronic pain safe for humans?

Cognitive behavioral therapy for chronic pain (CBT-CP), including its computer-based versions, is considered safe for humans and is an effective alternative to opioid pain medications. ^{1 2 3 4 6}

Is the treatment CBT4CBT COPES a promising treatment for chronic pain in people using opioids?

Yes, CBT4CBT COPES is a promising treatment for chronic pain. It is based on cognitive-behavioral therapy, which has been shown to be effective in reducing pain and related problems. This type of therapy can be delivered through technology, making it more accessible to people who might not have easy access to therapists. It is a safe alternative to using opioids for pain management. ^{2 3 6 7 8}

How is the CBT4CBT COPES treatment different from other treatments for chronic pain?

CBT4CBT COPES is unique because it is a computer-based cognitive behavioral therapy specifically designed for chronic pain in patients undergoing opioid treatment, making it more accessible and potentially more convenient than traditional in-person therapy sessions. ^{2 3 6 7 8}

Research Team

Alicia Heapy, PhD

Principal Investigator

Yale University

Eligibility Criteria

Adults over 18 with opioid use disorder (OUD) who are on methadone or buprenorphine treatment and have chronic pain. They must be able to walk a block, speak English at a basic level, and not have severe health issues or untreated mental disorders that could interfere with the study.

Inclusion Criteria

You meet the official guidelines for opioid use disorder (OUD) according to the DSM-5.

I am currently in a methadone or buprenorphine program at Liberation.

I am 18 years old or older.

Exclusion Criteria

Inability to read, write, and speak English at a third grade level (for reading informed consent)

I am scheduled for surgery to manage my pain.

Pending legal action or planned relocation that makes it unlikely they would be able to complete the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CBT4CBT-COPES or standard care for 12 weeks, with weekly meetings and assessments

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up interviews at 1, 3, and 6 months post-treatment

6 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• CBT4CBT COPES

Trial Overview The trial is testing an integrated web-based program combining cognitive-behavioral therapy (CBT4CBT) and Cooperative Pain Education Self-Management (COPES). It aims to improve adherence to medication-assisted treatment for OUD and manage chronic pain better than standard care alone.

Participant Groups

Group I: CBT4CBT-Copes Experimental Treatment 1 Intervention

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.

Group II: Standard care treatment as usual (TAU) Active Control 1 Intervention

Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

CBT4CBT COPES is already approved in United States for the following indications:

Approved in United States as CBT4CBT COPES for:

• Chronic pain management in individuals treated with buprenorphine or methadone

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The COPES trial demonstrated that interactive voice response-based cognitive behavioral therapy (IVR-CBT) is as effective as in-person CBT for managing chronic back pain, with similar reductions in pain intensity after 3 months.

IVR-CBT also showed lower dropout rates, suggesting it may be a more accessible and convenient option for patients, enhancing their ability to engage in treatment compared to traditional in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. Heapy, AA., Higgins, DM., Goulet, JL., et al.[2019]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

In a study involving 290 veterans with chronic back pain, 54% declined to participate in cognitive behavioral therapy for chronic pain (CBT-CP) due to lack of interest, indicating low overall enrollment rates.

Patients not receiving opioid prescriptions were more likely to enroll in the trial, suggesting that those on opioids, who may benefit from alternative pain management strategies, are underrepresented in CBT-CP programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Participation in a Nonpharmacological Intervention for Chronic Back Pain. Higgins, DM., LaChappelle, KM., Serowik, KL., et al.[2019]

A randomized non-inferiority trial is being conducted with 230 patients suffering from chronic low back pain to compare the effectiveness of traditional in-person cognitive behavioral therapy (CBT) with an innovative interactive voice response (IVR)-based CBT, aiming to enhance access to treatment.

The primary goal is to assess pain intensity immediately after treatment, while secondary outcomes will evaluate pain-related interference, emotional functioning, and quality of life over time, potentially demonstrating that IVR-based CBT can effectively provide care to more patients without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. Heapy, AA., Higgins, DM., LaChappelle, KM., et al.[2022]

Web-based cognitive behavioral therapy (CBT) effectively reduced pain interference and intensity in patients with chronic musculoskeletal pain, regardless of whether they received additional phone-based support from nurses.

The study found no significant differences in pain-related outcomes between the group receiving nurse support and the control group, except for a slight improvement in sleep disturbance favoring the nurse support group, suggesting that web-based CBT alone may be a cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. Diab, R., Bomar, R., Slaven, J., et al.[2023]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

A group-based cognitive behavioral therapy (CBT) intervention for chronic pain, delivered in primary care settings, resulted in significant and sustained reductions in self-reported pain impact and pain-related disability over 12 months among 850 participants.

While the CBT intervention improved patient satisfaction with care and reduced benzodiazepine use, it did not significantly decrease opioid use, indicating that while CBT can help manage chronic pain, it may not affect opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. DeBar, L., Mayhew, M., Benes, L., et al.[2022]

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of Participation in a Nonpharmacological Intervention for Chronic Back Pain. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. [2021]